Clinical Trial Oversight Must Focus On Major Risks, FDA Says

Law360, New York (August 7, 2013, 2:18 PM EDT) -- The U.S. Food and Drug Administration on Tuesday advised drugmakers and medical device firms to fine-tune their oversight of clinical trials by focusing on the most important risks and advised manufacturers to consider making greater use of remote monitoring instead of on-site inspections.

In a guidance document, the FDA described several pieces of data as almost always critical to the integrity of a study, including verification of informed consent and adherence to criteria meant to exclude participation by patients who might be uniquely susceptible to a...
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